Training Required for All Research Team Members

All members of a research team that meet the definition of “engaged in research” are required to complete human subject protection (HSP) training.

Engaged Study Team Members: An individual is "engaged" in human subjects research when the individual, (i) intervenes or interacts with living individuals for research purposes; or (ii) obtains individually identifiable private information for research purposes [45 CFR 46.102(d),(f)].

The modules are grouped by categories of research. There are two modules for HSP training. Choose the module/group that best fits the type of research you normally conduct. Below are the two modules for HSP training:

Group 1. Biomedical research investigators and key personnel: Biomedical research is patient-oriented and involves the study of the mechanisms of human disease, therapies or interventions for disease, clinical trials, and development of new technology. Biomedical research includes oncology research.

Group 2. Social and behavioral research investigators and key personnel: Social and Behavioral research applies the behavioral and social sciences to the study of humans. This research is conducted by many academic disciplines to include but not limited to education, sociology, anthropology, economics, political science, and history.

For more information regarding HSP training and registering for the course in CITI click here.

For more information regarding HIPAA training and registering for the course in CITI click here.

Training Required for NIH Funded Investigators and Research Team Members

Training: Good Clinical Practice (GCP) Training

Who does this apply to?

All National Institute of Health (NIH) funded investigators and staff who are involved in the conduct, oversight, or management of clinical trials. The policy applies to all active grants and contracts, at any point in the life cycle of the clinical trial.

Definitions:

NIH Clinical Trial – A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include a placebo or other control) to evaluate the effects of those interventions [defined below], on health-related biomedical or behavioral outcomes.

Interventions – A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as surveys, education, and interviews.

There are three courses that are available for the training. The first course (Good Clinical Practice, US FDA Focus) should be completed by all research personnel involved in NIH supported clinical trials. This course incorporates relevant ICH principles. The remaining courses should be completed if relevant to your particular international research.